Presenter: Anastassia Negrouk
Anastassia Negrouk is holding master’s degree in Biology, she specialized during 5 years in cellular biology and biochemistry working in a university research laboratory focusing on cancer research.
She joined EORTC in 2000. First as data manager and, since 2002 as part of the intergroup office, which was set-up to facilitate collaborative trials run together by different academic research groups. In 2004, she became also part, and later the head of the regulatory affairs unit. She took on her current position of the head of the international regulatory and intergroup office in 2011, renamed recently into “International policy office”.
This knowledge of legislation appeared essential to define appropriate models of collaboration that would convene to and convince other academic networks wishing to collaborate with EORTC. With 14 years of experience setting-up international clinical trial collaborations, mainly with academic partners, she cumulates the experience of over 50 intergroup trials, including worldwide efforts in the field of rare cancers.
More recently, she also became responsible for the patient involvement project. Indeed, patient organization involvement in clinical research activities is essential. Therefore, project aims to maximize the involvement of patient organizations in EORTC’s activities while adapting to each of partner organization.
She has been closely following the implementation of EU legislation relevant to cancer clinical research. Starting with the implementation of the clinical trials directive and analysis of its impacts, the follow-up and analysis of EU legislation became integral part of her work. Over the past 3 years she has been closely involved in discussions with EU institutions about clinical trials regulation, data protection regulation, in vitro diagnostic regulation and the impact these texts may have on the academic cancer research.
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